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Article: Outcomes From Cytotoxic Chemotherapy Following Progression on Immunotherapy in Metastatic Melanoma: An Institutional Case-Series.

Gaughan, Elizabeth M / Horton, Bethany J

2022 Volume 12, Page(s) 855782

Abstract: Introduction: The role of chemotherapy in the management of advanced melanoma is limited due to low response rates and short survival. Improved outcomes to chemotherapy administered after immunotherapy for metastatic melanoma and other solid tumors have ...

Abstract	Introduction: The role of chemotherapy in the management of advanced melanoma is limited due to low response rates and short survival. Improved outcomes to chemotherapy administered after immunotherapy for metastatic melanoma and other solid tumors have been reported. We studied the outcomes of subjects treated at the University of Virginia (UVA) with chemotherapy following progression on prior systemic immunotherapy and compared the results with the existing literature. Materials and methods: Subjects were identified through an institutional database of patients treated with immunotherapy at UVA. Demographic, pathologic and clinical factors were collected, along with dates of therapy, investigator-assessed best response as per Response Evaluation Criteria for Solid Tumors version 1.1 and dates of death or last follow up. Kaplan-Meier survival estimates and log-rank tests were used to perform time to event analysis of progression free survival and overall survival. Results: Forty-five patients were identified who met the inclusion criteria including 24 men and 21 women with a median age of 61 years. All patients had received at least one line of immunotherapy including 64.4% with prior anti-PD1 treatment. The cytotoxic chemotherapy regimens used included carboplatin with paclitaxel (55.6%), temozolomide (31.1%) and Discussion: Our results reveal that receipt of immunotherapy prior to chemotherapy for metastatic melanoma does not appear to improve the benefit of chemotherapy. The palliation of symptoms, maintenance of performance status and disease control may be valuable for some patients during this time of robust research and discovery for metastatic melanoma.
Language	English
Publishing date	2022-04-28
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2022.855782
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Article: Case Report: Dynamic overlap of melanoma, sarcoidosis, and targeted therapy for

Dar, Nakul / Gradecki, Sarah E / Gaughan, Elizabeth M

Frontiers in oncology

2023 Volume 13, Page(s) 1217179

Abstract: Targeted therapies, including BRAF and MEK inhibitors, are valuable treatment options for patients with unresectable or metastatic BRAF V600-mutant melanoma. With the improvement in survival seen with modern melanoma therapeutics, clinicians are learning ...

Abstract	Targeted therapies, including BRAF and MEK inhibitors, are valuable treatment options for patients with unresectable or metastatic BRAF V600-mutant melanoma. With the improvement in survival seen with modern melanoma therapeutics, clinicians are learning the variable patterns associated with extended clinical courses. Sarcoidosis is characterized by non-caseating granulomatous inflammation of unknown etiology, often presenting with cutaneous, lung, or lymph node involvement. There is a known association between sarcoidosis and melanoma, and sarcoidosis is increasingly seen and described in the setting of anti-melanoma therapy. The challenge for clinicians is to differentiate between sarcoid-related and malignancy-related findings, which may follow a variable course over years. We present two cases of BRAF and MEK inhibitor-related sarcoidosis in patients with melanoma and review the literature. The dynamic nature of the clinical and radiographic findings impacted patient management and clinical decisions for years of their treatment course.
Language	English
Publishing date	2023-08-29
Publishing country	Switzerland
Document type	Case Reports
ZDB-ID	2649216-7
ISSN	2234-943X
ISSN	2234-943X
DOI	10.3389/fonc.2023.1217179
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Article ; Online: Sarcoidosis, malignancy and immune checkpoint blockade.

Gaughan, Elizabeth M

Immunotherapy

2017 Volume 9, Issue 13, Page(s) 1051–1053

MeSH term(s)	Antineoplastic Agents, Immunological/adverse effects ; Antineoplastic Agents, Immunological/therapeutic use ; Diagnosis, Differential ; Humans ; Immunosuppressive Agents/therapeutic use ; Ipilimumab/adverse effects ; Neoplasms/complications ; Neoplasms/drug therapy ; Sarcoidosis/diagnosis ; Sarcoidosis/drug therapy ; Sarcoidosis/etiology ; Sarcoidosis/pathology ; Steroids/therapeutic use
Chemical Substances	Antineoplastic Agents, Immunological ; Immunosuppressive Agents ; Ipilimumab ; Steroids
Language	English
Publishing date	2017-10-10
Publishing country	England
Document type	Editorial
ISSN	1750-7448
ISSN (online)	1750-7448
DOI	10.2217/imt-2017-0128
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Article ; Online: Multiple evanescent white dot syndrome-like reaction associated with ipilimumab and nivolumab immune checkpoint inhibitor therapy for metastasis of choroidal melanoma.

Duong, Ryan T / Ambati, Naveen R / Peddada, Krishi V / Elghawy, Omar / Gaughan, Elizabeth M / Shildkrot, Yevgeniy

American journal of ophthalmology case reports

2022 Volume 25, Page(s) 101351

Abstract: Purpose: To present a rare case of multiple evanescent white dot syndrome (MEWDS)-like presentation associated with immune checkpoint inhibitor therapy for metastatic choroidal melanoma.: Observations: A 67-year-old non-myopic Caucasian female ... ...

Abstract	Purpose: To present a rare case of multiple evanescent white dot syndrome (MEWDS)-like presentation associated with immune checkpoint inhibitor therapy for metastatic choroidal melanoma. Observations: A 67-year-old non-myopic Caucasian female presented with bilateral worsening vision, flashes, and floaters after receiving two doses of ipilimumab and nivolumab for metastatic class 2 peripheral choroidal melanoma. Fundus imaging of the right eye revealed hypopigmented, extra-foveal scattered chorioretinal lesions with foveal granularity. Fluorescein angiogram and autofluorescence of the right eye demonstrated corresponding hyperfluorescent and hyperautofluorescent lesions in a wreath-like configuration. Optical coherence tomography of the right eye revealed subretinal fluid. Due to concurrent systemic side effects, checkpoint inhibitor therapy was paused and the patient was started on oral prednisone. At her one month follow up visit, her vision in her right eye returned to baseline and subretinal fluid resolved. Conclusions: This is the first reported case of a MEWDS-like chorioretinopathy after two cycles of ipilimumab/nivolumab therapy for metastatic choroidal melanoma. As immune checkpoint inhibitor therapy is still an evolving field, more research is needed to characterize ocular side effect profiles of these agents.
Language	English
Publishing date	2022-01-31
Publishing country	United States
Document type	Case Reports
ISSN	2451-9936
ISSN (online)	2451-9936
DOI	10.1016/j.ajoc.2022.101351
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Article ; Online: PD-L1 and MHC Class I Expression in High-grade Ovarian Cancers, Including Platinum-resistant Recurrences Treated With Checkpoint Inhibitor Therapy.

Griesinger, Laurie / Nyarko-Odoom, Akua / Martinez, Santos Acosta / Shen, Nancy W / Ring, Kari L / Gaughan, Elizabeth M / Mills, Anne M

Applied immunohistochemistry & molecular morphology : AIMM

2023 Volume 31, Issue 4, Page(s) 197–203

Abstract: Immune-modulating therapies targeting the programmed cell death-1/programmed cell death ligand-1 (PD-L1) immunosuppressive system have been used successfully in many solid tumor types. There is evidence that biomarkers such as PD-L1 and major ... ...

Abstract	Immune-modulating therapies targeting the programmed cell death-1/programmed cell death ligand-1 (PD-L1) immunosuppressive system have been used successfully in many solid tumor types. There is evidence that biomarkers such as PD-L1 and major histocompatibility complex (MHC) class I help identify candidates for anti-programmed cell death-1/PD-L1 checkpoint inhibition, though the evidence is limited in ovarian malignancies. PD-L1 and MHC Class I immunostaining was performed on pretreatment whole tissue sections in 30 cases of high-grade ovarian carcinoma. The PD-L1 combined positive score was calculated (a score of ≥1 is considered positive). MHC class I status was categorized as an intact or subclonal loss. In patients who received immunotherapy, drug response was assessed using RECIST criteria. PD-L1 was positive in 26 of 30 cases (87%; combined positive score: 1 to 100). Seven of 30 patients showed subclonal loss of MHC class I (23%), and this occurred in both PD-L1 negative (3/4; 75%) and PD-L1 positive (4/26; 15%) cases. Only 1 of 17 patients who received immunotherapy in the setting of a platinum-resistant recurrence responded to the addition of immunotherapy, and all 17 died of disease. In the setting of recurrent disease, patients did not respond to immunotherapy regardless of PD-L1/MHC class I status, suggesting that these immunostains may not be effective predictive biomarkers in this setting. Subclonal loss of expression of MHC class I occurs in ovarian carcinoma, including in PD-L1 positive cases, suggesting that the 2 pathways of immune evasion may not be mutually exclusive and that it may be important to interrogate MHC class I status in PD-L1 positive tumors to identify additional immune evasion mechanisms in these tumors.
MeSH term(s)	Humans ; Female ; B7-H1 Antigen/metabolism ; Histocompatibility Antigens Class I/metabolism ; Ovarian Neoplasms/pathology ; Immunotherapy ; Biomarkers
Chemical Substances	B7-H1 Antigen ; Histocompatibility Antigens Class I ; Biomarkers
Language	English
Publishing date	2023-02-22
Publishing country	United States
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	1473273-7
ISSN	1533-4058 ; 1062-3345 ; 1541-2016
ISSN (online)	1533-4058
ISSN	1062-3345 ; 1541-2016
DOI	10.1097/PAI.0000000000001108
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Article ; Online: Gastric Neuroendocrine Tumor Treatment and Survival Outcome Depends on Facility Type.

Platoff, Rebecca M / Lou, Johanna / Bush, Kathryn / Zhu, Clara / Spitz, Elizabeth / Gaughan, John P / Atabek, Umur / Spitz, Francis / Hong, Young K

The American surgeon

2022 Volume 89, Issue 11, Page(s) 4334–4343

Abstract: Background: Gastric neuroendocrine tumors (gNETs) are rare cancers for which surgery may improve survival. We aim to determine if facility type affects treatment and survival outcomes.: Methods: The NCDB was queried for patients with gNET from 2004- ... ...

Abstract	Background: Gastric neuroendocrine tumors (gNETs) are rare cancers for which surgery may improve survival. We aim to determine if facility type affects treatment and survival outcomes. Methods: The NCDB was queried for patients with gNET from 2004-2016 and stratified into Academic/Research Program (ARP), Community Cancer Program (CCP), Comprehensive Community Cancer Program (CCCP), or Integrated Network Cancer Program (INCP). Overall survival along with clinical and demographic features was compared. Results: Median survival was improved in patients treated at an academic program: 137.3 months versus 88.0, 96.3, and 100.2 for CCP, CCCP, INCP, respectively (P < .0001). Patients treated at academic centers were more likely to have surgery (64.2% vs 59.1%, 57.5%, 51.4%, P < .0001). After propensity matching for age, race, grade, stage, insurance status, and comorbidity score, survival benefit from treatment at an academic center remained (P = .03), particularly for patients undergoing surgery (P < .0001) and chemotherapy (P = .04). Conclusion: Patients with gNET treated at an academic hospital had improved median survival after propensity matching and may benefit from treatment at academic rather than community medical centers.
MeSH term(s)	Humans ; Neuroendocrine Tumors/surgery ; Carbonyl Cyanide m-Chlorophenyl Hydrazone ; Hospitals ; Pancreatic Neoplasms ; Retrospective Studies ; Treatment Outcome
Chemical Substances	Carbonyl Cyanide m-Chlorophenyl Hydrazone (555-60-2)
Language	English
Publishing date	2022-06-19
Publishing country	United States
Document type	Journal Article
ZDB-ID	202465-2
ISSN	1555-9823 ; 0003-1348
ISSN (online)	1555-9823
ISSN	0003-1348
DOI	10.1177/00031348221109460
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Article: Relevance of the Updated Recursive Partitioning Analysis (U-RPA) Classification in the Contemporary Care of Patients with Brain Metastases.

Fadul, Camilo E / Sarai, Guneet / Bovi, Joseph A / Thomas, Alissa A / Novicoff, Wendy / Anderson, Roger / Amidon, Ryan F / Schuetz, Samantha / Singh, Rohit / Chang, Amy / Gentzler, Ryan D / Gaughan, Elizabeth M / Sheehan, Jason P

Cancers

2023 Volume 15, Issue 12

Abstract: Patients with brain metastases (BMETS) need information about the prognosis and potential value of treatment options to make informed therapeutic decisions, but tools to predict survival in contemporary practice are scarce. We propose an Updated ... ...

Abstract	Patients with brain metastases (BMETS) need information about the prognosis and potential value of treatment options to make informed therapeutic decisions, but tools to predict survival in contemporary practice are scarce. We propose an Updated Recursive Partitioning Analysis (U-RPA) instrument to predict survival and benefit from brain-directed treatment (BDT) of contemporary patients. This was a retrospective analysis of patients with BMETS treated between 2017 and 2019. With survival as the primary endpoint, we calculated the U-RPA and generated estimates using Kaplan-Meier curves and hazard ratios. Of 862 eligible patients, 752 received BDT and 110 received best supportive care (BSC). Median overall survival with BDT and BSC was 9.3 and 1.3 months, respectively. Patients in RPA class 1, 2A, 2B and 3 who underwent BDT had median survival of 28.1, 14.7, 7.6 and 3.3 months, respectively. The median survival for patients in RPA 3 who received BDT (
Language	English
Publishing date	2023-06-20
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527080-1
ISSN	2072-6694
ISSN	2072-6694
DOI	10.3390/cancers15123255
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Article ; Online: Multicenter Experience with Neoadjuvant Therapy in Melanoma Highlights Heterogeneity in Contemporary Practice.

Rhodin, Kristen E / Gaughan, Elizabeth M / Raman, Vignesh / Salama, April K / Hanks, Brent A / Shah, Riddhishkumar / Tyler, Douglas S / Slingluff, Craig L / Beasley, Georgia M

Annals of surgery

2022 Volume 277, Issue 6, Page(s) e1306–e1312

Abstract: Objective: To determine the feasibility and impact of neoadjuvant therapy (NT) in patients who present with advanced melanoma amenable to surgical resection.: Summary background data: Given current effective systemic therapy for melanoma, the use of ... ...

Abstract	Objective: To determine the feasibility and impact of neoadjuvant therapy (NT) in patients who present with advanced melanoma amenable to surgical resection. Summary background data: Given current effective systemic therapy for melanoma, the use of NT is being explored in patients with advanced melanoma with disease amenable to surgical resection. Methods: Prospective data from 3 institutions was obtained in patients with clinically evident Stage III/IV melanoma who underwent NT. The primary objective was to compare recurrence-free survival between patients who had pathologic complete response (pCR) to those with persistent disease. Results: NT was offered to 45 patients, with 43 patients initiating various NT regimens including PD-1 antagonist (PD-1) therapy (N = 16), PD-1 plus ipilimumab (N = 10), BRAF/MEK inhibitor therapy (N = 14), a combination of those three (N = 1), and talimogene laherparepvec (TVEC) (N = 2). Thirty-two (74.1%) patients underwent surgery whereas 11 patients did not undergo surgery for these reasons: clinical CR (N = 7), progressive disease not amenable to resection (N = 3), and ongoing therapy (N = 1). 12 of 32 patients (37.5%) had pCR with these therapies: PD-1 (N = 4), PD-1 plus ipilimumab (N = 2), BRAF/MEK (N = 4), combination (N = 1), and TVEC (N = 1). At median follow-up of 16.4 months there was only 1 recurrence in the pCR group and patients with a pCR had significantly improved recurrence-free survival compared to patients without pCR (p = 0.004). Conclusions: Despite variability in NT regimens across institutions, NT for melanoma is feasible and associated with improved prognosis in patients who achieve a pCR. Maximizing rates of pCR could improve prognosis for patients with advanced melanoma.
MeSH term(s)	Humans ; Ipilimumab/therapeutic use ; Melanoma/drug therapy ; Mitogen-Activated Protein Kinase Kinases/therapeutic use ; Neoadjuvant Therapy ; Oncolytic Virotherapy ; Programmed Cell Death 1 Receptor/therapeutic use ; Prospective Studies ; Proto-Oncogene Proteins B-raf/genetics ; Skin Neoplasms/drug therapy ; Melanoma, Cutaneous Malignant
Chemical Substances	Ipilimumab ; Mitogen-Activated Protein Kinase Kinases (EC 2.7.12.2) ; Programmed Cell Death 1 Receptor ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1)
Language	English
Publishing date	2022-07-07
Publishing country	United States
Document type	Multicenter Study ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	340-2
ISSN	1528-1140 ; 0003-4932
ISSN (online)	1528-1140
ISSN	0003-4932
DOI	10.1097/SLA.0000000000005459
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Article ; Online: Phase I/II clinical trial of a helper peptide vaccine plus PD-1 blockade in PD-1 antibody-naïve and PD-1 antibody-experienced patients with melanoma (MEL64).

Vavolizza, Rick Daniel / Petroni, Gina R / Mauldin, Ileana S / Chianese-Bullock, Kimberly A / Olson, Walter C / Smith, Kelly T / Dengel, Lynn T / Haden, Kathleen / Grosh, William W / Kaur, Varinder / Varhegyi, Nikole / Gaughan, Elizabeth M / Slingluff, Craig L

Journal for immunotherapy of cancer

2022 Volume 10, Issue 9

Abstract: Background: A vaccine containing 6 melanoma-associated peptides to stimulate helper T cells (6MHP) is safe, immunogenic, and clinically active. A phase I/II trial was designed to evaluate safety and immunogenicity of 6MHP vaccines plus programmed death ... ...

Abstract	Background: A vaccine containing 6 melanoma-associated peptides to stimulate helper T cells (6MHP) is safe, immunogenic, and clinically active. A phase I/II trial was designed to evaluate safety and immunogenicity of 6MHP vaccines plus programmed death 1 (PD-1) blockade. Participants and methods: Participants with advanced melanoma received 6MHP vaccines in an incomplete Freund's adjuvant (6 vaccines over 12 weeks). Pembrolizumab was administered intravenously every 3 weeks. Tumor biopsies at baseline and day 22 were analyzed by multiplex immunohistochemistry. Primary end points were safety (Common Terminology Criteria for Adverse Events V.4.03) and immunogenicity (ex vivo interferon-γ ELISpot assay). Additional end points included changes in the tumor microenvironment (TME) and clinical outcomes. Results: Twenty-two eligible participants were treated: 6 naïve to PD-1 antibody (Ab) and 16 PD-1 Ab-experienced. Median follow-up was 24.4 months. Most common treatment-related adverse events (any grade) included injection site reactions, fatigue, anemia, lymphopenia, fever, elevated aspartate aminotransferase, pruritus, and rash. Treatment-related dose-limiting toxicities were observed in 3 (14%) participants, which did not cross the study safety bound. A high durable T cell response (Rsp) to 6MHP was detected in only one participant, but twofold T cell Rsps to 6MHP were detected in 7/22 (32%; 90% CI (16% to 52%)) by week 13. Objective clinical responses were observed in 23% (1 complete response, 4 partial responses), including 4/6 PD-1 Ab-naïve (67%) and 1/16 PD-1 Ab-experienced (6%). Overall survival (OS) was longer for PD-1 Ab-naïve than Ab-experienced participants (HR 6.3 (90% CI (2.1 to 28.7)). In landmark analyses at 13 weeks, OS was also longer for those with T cell Rsps (HR 6.5 (90% CI (2.1 to 29.2)) and for those with objective clinical responses. TME evaluation revealed increased densities of CD8 Conclusions: Treatment with the 6MHP vaccine plus pembrolizumab was safe, increased intratumoral lymphocytes, and induced T cell Rsps associated with prolonged OS. The low T cell Rsp rate in PD-1 Ab-experienced participants corroborates prior murine studies that caution against delaying cancer vaccines until after PD-1 blockade. The promising objective response rate and OS in PD-1 Ab-naïve participants support consideration of a larger study in that setting.
MeSH term(s)	CD8-Positive T-Lymphocytes ; Cancer Vaccines ; Humans ; Melanoma/drug therapy ; Programmed Cell Death 1 Receptor ; Tumor Microenvironment ; Vaccines, Subunit/therapeutic use
Chemical Substances	Cancer Vaccines ; Programmed Cell Death 1 Receptor ; Vaccines, Subunit
Language	English
Publishing date	2022-09-11
Publishing country	England
Document type	Clinical Trial, Phase I ; Clinical Trial, Phase II ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	2719863-7
ISSN	2051-1426 ; 2051-1426
ISSN (online)	2051-1426
ISSN	2051-1426
DOI	10.1136/jitc-2022-005424
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Article ; Online: Severe combined cardiac and neuromuscular toxicity from immune checkpoint blockade: an institutional case series.

Arora, Puja / Talamo, Laura / Dillon, Patrick / Gentzler, Ryan D / Millard, Trish / Salerno, Michael / Slingluff, Craig L / Gaughan, Elizabeth M

Cardio-oncology (London, England)

2020 Volume 6, Page(s) 21

Abstract: Background: Immune checkpoint inhibition is part of standard systemic management for many advanced malignancies. Toxicities from this treatment approach are unpredictable, though usually reversible with management per established guidelines. Some ... ...

Abstract	Background: Immune checkpoint inhibition is part of standard systemic management for many advanced malignancies. Toxicities from this treatment approach are unpredictable, though usually reversible with management per established guidelines. Some patients suffer major morbidity and treatment-related mortality from these agents in an unpredictable manner. Cardiac and neurologic complications are rare, but can result in serious clinical consequences. Methods: We describe the presentation, management, and outcomes of eight sequential cases of combined cardiac and neurologic toxicities resulting in severe illness and demonstrating lack of rapid response to immunosuppression. Results: Our cohort consisted of six males and two females with an average age of 73.5 years (61-89 years). There were four patients with melanoma, and one patient each with urothelial carcinoma, renal cell carcinoma, breast cancer, and non-small cell lung cancer. Four patients received combination immunotherapy and four patients received monotherapy. The median time to presentation from treatment initiation was 27 days (11-132 days). All patients had a cardiovascular and neurologic toxicity, and most had hepatitis and myositis. The cardiac signs and symptoms were the prominent initial features of the clinical presentation. Each patient was managed by a multidisciplinary team and received a range of immunosuppressive agents. All patients died as a consequence of the immune related adverse events. Conclusions: The evaluation of patients with cardiac adverse events from immunotherapy, should include assessment of overlapping toxicities such as myasthenia gravis and myositis. Providers should be aware of the potential for an extended duration of disability and slow improvement for certain toxicities as these expectations may factor prominently in goals of care decisions.
Language	English
Publishing date	2020-09-23
Publishing country	England
Document type	Journal Article
ISSN	2057-3804
ISSN (online)	2057-3804
DOI	10.1186/s40959-020-00076-6
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